# K041947: I3 System-Abd Diagnostic Ultrasound

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Imaging, Inc.
- Decided: Aug 16, 2004 after 27 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K902007 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902007: I3SYSTEM-Abd, Innovative Imaging, Inc. (1990) Summary page 1.

## Recalls of this device
- Sep 25, 2007 · Not classified · Z-0148-2008: Incorrect IOL calculations: software behavior with Version 3.0 Eye Cubed Ultrasound systems running Biometry A-scan enabled Version 3.0.0 software can cause incorrect IOL calculations.

## Indications for use
Cataracts Retinal Detachments (a separation of the retina from the middle coat of the eyeball) Orbital Lesions Tumors Foreign bodies Inflammation Vascular Irregularities

Source page: https://510kreport.com/device/K041947
Methodology: https://510kreport.com/methodology